Spec, Regulatory Affairs - Sr- San Juan Capistrano, California - Monday to Friday
Provide regulatory guidance in product design, clinical studies, market authorization strategies, labeling, advertising, and product withdrawals and recalls. Provide pre-market and post-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives. Supports applicable regulations including Local, State, Federal and/or International requirements.
• Provide regulatory guidance in product design, clinical studies, market authorization strategies, and labeling.
• Review and edit product submissions and other communications prepared by junior department members.
• Act as regulatory subject matter expert for junior department members.
• Provide pre-market and post-market regulatory strategy to ensure regulatory compliance and advance commercial objectives.
• Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare global regulatory applications, as well as internal regulatory file documentation.
• Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.
• Independently communicate with regulatory agencies on pre-market and post-market related issues.
• Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
• Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
• Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Review related regulatory publications and documents to stay informed about current regulatory actions.
• Interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
• Provide back up to the Regulatory Affairs Director as needed.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.
Provide technical and editorial direction to junior department members.
EDUCATION and/or EXPERIENCE
BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required. Must have extensive knowledge of U.S, Canadian, European and other International In vitro diagnostic regulations and standards. At least five years of pre-market regulatory experience in IVD industry. Clinical research experience desired, but not required. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Must be able to work well in team environment with individuals from diverse functional areas, as well as work independently. Must demonstrate leadership skills without having direct authority. Must have experience working on project/product from concept to market introduction. Must have proven analytical capabilities, solid understanding of manufacturing and change control, and awareness of regulatory trends. Must have experience in negotiation of technical issues with internal and external functions including health authorities.
Must be detailed oriented. Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations. Requires ability to speak effectively before groups of customers or employees of organization. Requires the ability of organize information to compose reports, documents and presentations. Requires knowledge of scientific, medical and regulatory terms. Requires ability to understand and interpret regulatory requirements and technical standards. Must have the ability to write and organize complex reports and correspondence to regulatory agencies. Requires ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations. Requires ability to edit and proof documents with detailed accuracy. Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
Must have analytical reasoning and problem solving ability. Must be able to analyze quantitative information. Must have experience working with moderate to complex statistical techniques. Must have ability to calculate dilutions, titrations, and other laboratory methodologies. Must be skilled in basic algebra and geometry. Must be able to perform unit conversions. Must be able to tabulate random data and translate data into text conclusions.
Must have the ability to define problems, collect data, establish facts, and draw valid conclusions. Must have the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Must use logical thought processes and deductive reasoning. Must have the ability to apply rational sense to carry out instructions furnished in written, oral, or diagram form. Possess the ability to deal with problems involving several variables in non-standardized situations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. . Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Receives no instructions on routine work, general instructions on new assignments. Attention to detail. Must demonstrate the ability to get results despite a large workload, competing demands in a fast paced environment. Must have the ability to understand and interpret regulatory requirements and technical standards. Must possess the ability to identify issues and initiative to recommend solutions. Must have the ability to understand and translate implications of regulatory requirements on company policies and strategies.
CERTIFICATES, LICENSES, REGISTRATIONS
US-RAC preferred but not required.
While performing the duties of this job, the employee is regularly required to sit, hear, and use hands to finger, handle, or feel, and reach with hands and arms. The employee is also occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. The employee must be able to see up close, color, and have distance vision.
The noise level in the work environment is usually moderate.
OSHA RISK CATEGORY
Category II - May encounter potential exposure.